Regulation (2010:1167) If Fees For The State Control Of Pharmaceuticals

Original Language Title: Förordning (2010:1167) om avgifter för den statliga kontrollen av läkemedel

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2010:1167

Chapter 1. Introductory provisions



1 §/expires U: 2016-01-01/

This regulation contains provisions relating to fees

According to section 25 of the medicines Act (1992:859).



1 section/entry into force: 01/01/2016

This regulation provides for the fees referred to in chapter 15. the medicines Act (2015:315).

Regulation (2015:465).



2 §/expires U: 2016-01-01/

The terms and expressions used in pharmaceutical law

(1992:859) has the same meaning in this regulation.

In addition, '



1. natural remedies: medicinal products where the active

components have a natural origin, are not

overly processed and constitutes an animal, bacterial culture,

mineral or salt solution and that is only appropriate for

self care in accordance with the well proven domestic tradition

or tradition in countries with respect to

drug use is Sweden near,



2. some topical medications: medications for the treatment of

simpler diseases in humans and animals, such as

wound ointments, inhaled the oils, antiseptic solutions,

liniments and the like, where the active

components have a well-established medicinal use

with recognised efficacy and an acceptable level of safety,



3. parallel imports: imports into Sweden from a country in the

European economic area (EEA) of a

drugs that are approved for sale in Sweden and in

the country of export, which is managed by someone other than the manufacturer

or the marketing authorisation holder,



4. stock preparation: a standardized medicines that do not

is approved for sale and produced by a

pharmacies,



5. license: authorization to sell a drug under paragraph 5 of the

the third paragraph of the medicines Act,



6. the national license: a license in respect of a stock preparation,



7. duplikatansökan: an application relating to an approval

for sale that completely corresponds to an existing

approval or another application for approval except when

the case of the name of the medicinal product and marketing

marketing authorisation,



8. duplicates: drugs that have been approved on the basis of a

duplikatansökan and which still represents

the reference medicine except for name and holders

of the marketing authorization,



9. major variation of type II: modification which is not a

expanded approval which may have a significant impact on

the quality, safety or efficacy of the medicinal product,



10. Ce certificate for batch release: document

Specifies that an official statement release regarding

vaccines and blood products for human use has taken place prior to the

release on the Swedish market,



11. abridged application: application for approval for

sales on the basis of documentation for a

reference medicinal product pursuant to section 8(a) of the medicines Act,



12. approval or registration under the

decentralised or mutual procedure when

Sweden is concerned Member State: an approval or a

registration based on the reference Member State

basis for application of the decentralized

procedure or the recognition of an authorisation or

registration in another State of the European

economic area,



13. request to Sweden to work as

the reference Member State in a decentralised or

reciprocal procedure: request to Sweden to work

as the reference Member State in a decentralised procedure

According to § 6 d medicines Act or to the FDA

shall prepare or complete an assessment report in

connection with application in another Member State for recognition

of a in Sweden announced the approval or registration.



2 section/entry into force: 01/01/2016

The terms and expressions used in the medicines Act (2015:315) has the same meaning in this regulation. In addition, '



1. natural remedies: medicinal active ingredient (s) has a natural origin, are not too processed and constitutes an animal, bacterial culture, mineral or salt solution and that is only appropriate for self-management in accordance with well proven domestic tradition or traditions in countries with respect to the use of drugs is Sweden near,



2. some topical medications: medications for the treatment of diseases in humans and animals, such as ulcer ointments, inhaled the oils, antiseptic solutions, liniments and the like, where the active substances have a well-established medicinal use with recognised efficacy and an acceptable level of safety,



3. parallel imports: arrival to Sweden from a country within the European economic area (EEA) of a drug that is approved for sale in Sweden and in the export country, which is managed by someone other than the manufacturer or the holder of the marketing authorisation,



4. stock preparation: a standardized drug that is not approved for sale and made by a pharmacy,



5. license: authorization to sell a drug pursuant to Chapter 4.

section 10, second paragraph the medicines Act,



6. the national license: a license in respect of a stock preparation,



7. duplikatansökan: an application for a marketing authorisation that completely corresponds to an existing approval or another application for approval except for the name of the medicinal product and the holders of the existing authorisation,



8. duplicates: medicinal products authorised for sale after a duplikatansökan and still correspond to the reference product, except for the name and owner of the existing authorisation,



9. major variation of type II: modification that is not an extension of the marketing authorisation and which may have a significant impact on the quality, safety or efficacy of the medicinal product,



10. Ce certificate for batch release: a document that indicates that an official statement release regarding vaccines and blood products for human use has taken place prior to release on the Swedish market,



11. abridged application: the application for marketing authorisation on the basis of the documentation of a reference medicinal product pursuant to Chapter 4. section 13 medicines Act,



12. the authorisation or registration in accordance with the decentralised or mutual procedure when Sweden are affected Member country: an authorisation or a registration for sale based on the reference member country's input in the implementation of the decentralised procedure or a recognition of an authorisation or a registration granted in another country within the EEA,



13. request to Sweden to act as reference Member State in a decentralised or mutual procedure: request for Sweden to act as reference Member State in a decentralised procedure pursuant to Chapter 4. § 9 the medicines Act or agency shall develop or complete an assessment report in connection with the application in another Member State for recognition of an authorisation or a registration granted in Sweden. Regulation (2015:465).



section 3 of the FDA hears questions about fees according to

This regulation.



section 4 of the Fee to be charged in the cases set out in this

Regulation.



Chapter 2. Application fees



Authorisation of medicinal products for sale



section 1 the fee for an application for authorisation of medicinal products for

the sale shall be paid as follows:



1. medicinal products for Human use



a) complete application, with the exception of the b-h 400 000 kr



b) application relating to a generic medicine

the reference medicinal product is not authorised in the

Sweden 400 000 kr



c) application for a radiopharmaceutical 65 000 kr



d) application relating to an allergen 65 000 kr



e) application designed herbal remedies or

some topical medications 100 000 kr



f) abridged application in cases where

the reference medicine authorised in Sweden 200 000 kr



g) duplikatansökan 30 000 kr



h) application designed parallel imported

medicine 25 000 kr



2. Medicinal products for veterinary use



a) complete application, with the exception of (b) – (f) 200 000 kr



b) application relating to a generic medicine

the reference medicinal product is not authorised in the

Sweden 200 000 kr



c) application designed herbal remedies or

some topical medications 50 000 kr



d) abridged application in cases where

the reference medicine authorised in Sweden 100 000 kr



e) duplikatansökan 15 000 kr



f) application designed parallel imported

medicine 12 500 kr



The fee for all routes of administration, strengths and

pharmaceutical form of the same drug name submitted

for the assessment at the same time. The fee for the application for

parallel imported medicinal products as referred to in the first subparagraph 1 (h)

and (f) concerned all the strengths and pharmaceutical forms

with the same drug name from the same country as

submitted for assessment at the same time.



/Rubriken expires U: 2016-01-01/

Approval of medicines for sale under the

decentralised or mutual procedure when

Sweden is the Member State concerned



/Rubriken entry into force: 01/01/2016

Approval of medicines for sale under the decentralised or mutual procedure when Sweden are affected Member country



2 §/expires U: 2016-01-01/

Fee for the application for the authorisation of medicinal products for


sale under the decentralized or it

reciprocal procedure when Sweden are Member State concerned

shall be paid as follows:



1. medicinal products for Human use



a) complete application, with the exception of (b) – (d) 100 000 kr



b) application relating to a generic medicine

the reference medicinal product is not authorised in the

Sweden 100 000 kr



c) abridged application in cases where

the reference medicine authorised in Sweden 65 000 kr



d) duplikatansökan 30 000 kr



2. Medicinal products for veterinary use



a) complete application, with the exception of (b)-(d) € 5,000



b) application relating to a generic medicine

the reference medicinal product is not authorised in the

Sweden 50 000 kr



c) abridged application in cases where

the reference medicine authorised in Sweden 32 500 kr



d) duplikatansökan 15 000 kr



The fee for all routes of administration, strengths and

pharmaceutical form of the same drug name submitted

for the assessment at the same time.



2 section/entry into force: 01/01/2016

The fee for an application for the approval of medicines for sale under the decentralised or mutual procedure when Sweden are affected Member country shall be paid as follows:



1. Medicinal products a) complete application, with the exception of (b) – (d) 100 000 kr



b) application for a generic medicinal product, the reference medicinal product is not authorised in Sweden 100 000 kr



c) abridged application in cases where the reference medicine authorised in Sweden 65 000 kr



d) duplikatansökan 30 000 kr



2. veterinary medicinal products a) complete the application, with the exception of (b)-(d) € 5,000



b) application for a generic medicinal product, the reference medicinal product is not authorised in Sweden 50 000 kr



c) abridged application in cases where the reference medicine authorised in Sweden 32 500 kr



d) duplikatansökan 15 000 kr



The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

Extension of an existing authorisation



/Rubriken entry into force: 01/01/2016

Extension of an existing authorisation



3 §/expires U: 2016-01-01/

Fee for the application for extension must

be paid as follows:



1. medicinal products for Human use



(a) the application for extension), with

the exception of (b) and (c) 200 000 kr



b) application for extension relating to the

natural remedies or some topical medications 50 000 kr



c) application for recognition of an enlarged

approval in accordance with the decentralised or

the reciprocal procedure when Sweden are

Member State concerned 65 000 kr



2. Medicinal products for veterinary use



(a) the application for extension), with

the exception of (b) and (c) 100 000 kr



b) application for extension relating to the

natural remedies or some topical medications 50 000 kr



c) application for recognition of an enlarged

approval in accordance with the decentralised or

the reciprocal procedure when Sweden are

Member State concerned 32 500 kr



The fee for all routes of administration, strengths and

pharmaceutical form of the same drug name submitted

for the assessment at the same time and for the same type

by amending the conditions for authorisation.



3 section/entry into force: 01/01/2016

The fee for an application for the extension of the marketing authorisation shall be paid as follows:



1. Medicinal products a) application for extension, with the exception of (b) and (c) 200 000 kr



b) application for extension relating to herbal remedies or some topical medications 50 000 kr



c) application for recognition of an extension under the decentralised or mutual procedure when Sweden are affected Member country 65 000 kr



2. veterinary medicinal products (a)) the application for extension, with the exception of (b) and (c) 100 000 kr



b) application for extension relating to herbal remedies or some topical medications 50 000 kr



c) application for recognition of an extension under the decentralised or mutual procedure when Sweden are affected Member country 32 500 kr



The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time and the same type of modification of the conditions for approval. Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

Registration of herbal medicinal products and

extension of such registration



/Rubriken entry into force: 01/01/2016

Registration for the sale of traditional herbal medicinal products and extension of such registration



4 §/expires U: 2016-01-01/

The fee for an application for registration of a

traditional herbal medicinal product shall be paid in accordance with the

the following:



1. the application for registration of a

traditional herbal medicinal product 100 000 kr



2. the application for registration of a

traditional herbal medicinal products

contains a herbal substance or a

preparation or a combination thereof,

included in the list

drawn up by the European Commission, 50 000 kr



3. the application for recognition of a registration

of a traditional herbal medicines

under the decentralized or it

reciprocal procedure when Sweden are

Member State concerned 32 500 kr



4. Duplikatansökan 30 000 kr



5. the application relating to parallel imported

traditional herbal medicines, 25 000 kr



The fee for all routes of administration, strengths and

pharmaceutical form of the same drug name submitted

for the assessment at the same time. The fee for the application for

parallel imported medicinal products as referred to in the first subparagraph 5,

However, all strengths and pharmaceutical form of the same

drug name from the same exporting country that is submitted

for the assessment at the same time.



4 section/entry into force: 01/01/2016

The fee for an application for registration of sale of a traditional herbal medicinal product for human use shall be paid as follows:



1. the application for registration of a traditional herbal medicinal product for 100 000 kr



2. the application for registration of a traditional herbal medicinal product for human use that contains a herbal substance or a preparation or a combination thereof appearing on the list drawn up by the European Commission, 50 000 kr



3. the application for recognition of a registration of a traditional herbal medicinal product for human use in accordance with the decentralised or mutual procedure when Sweden are affected Member country 32 500 kr



4. Duplikatansökan 30 000 kr



5. the application relating to parallel imported traditional herbal medicinal products for 25 000 kr



The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. The fee for application for parallel imported medicinal products pursuant to the first paragraph 5, however, all strengths and pharmaceutical form of the same drug name from the same exporting country that is submitted for assessment at the same time. Regulation (2015:465).



§ 5/expires U: 2016-01-01/

The fee for an application for the extension of an existing

registration of a traditional herbal medicines

amounts to SEK 50,000. For an application for recognition of a

extended registration of a traditional herbal

drugs under the decentralised or mutual

procedure when Sweden are Member State concerned amounts

the fee to 16 250 kr.



§ 5/entry into force: 01/01/2016

The fee for an application for the extension of an existing registration for the sale of a traditional herbal medicinal product for human use is 50 000 kr. For an application for recognition of an expanded registration of a traditional herbal medicinal product for human use in accordance with the decentralised or mutual procedure when Sweden are affected Member country amounts to SEK 16 250 fee Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

The registration of homeopathic medicinal products



/Rubriken entry into force: 01/01/2016

Registration for the sale of homeopathic medicine



6 §/expires U: 2016-01-01/

For an application for registration of homeopathic

medicinal products for human use and veterinary medicinal products,

fee shall be paid as follows:



1. the application for registration of a

homeopathic medicinal products referred to in 2 (b) §

the medicines Act (1992:859) 4 000 kr



2. the application for recognition of a registration

of a homeopathic medicinal products according to the

decentralised or mutual

procedure when Sweden are Member State concerned 2 000 kr



The charge relates to a single simple medium, easy medium in a

dilution series or a composite medium with several

constituents.



6 §/entry into force: 01/01/2016

For an application for registration of sale of homeopathic medicinal products for human and veterinary medicinal products, the fee shall be paid as follows: 1. the application for registration of a homeopathic medicine 4 000 kr



2. the application for recognition of a registration of a homeopathic medicinal products according to the


decentralised or mutual procedure when Sweden are affected Member country 2 000 kr



The charge relates to a single simple means, simple means in a dilution series or a composite medium with more ingredients. Regulation (2015:465).



License and license



paragraph 7 of the licence fee payable under national license

the following:



1. medicinal products for Human use



National (a) application for license) 65 000 kr



b) application for license to meet the

special needs of medicines in individual cases 220 kr



2. Medicinal products for veterinary use



National (a) application for license) 32 500 kr



b) application for license to meet the

special needs of medicines in individual cases 220 kr



Licence for manufacture of medicinal products



section 8/expires U: 2016-01-01/

The fee for an application for authorisation of a professional

the manufacture of medicinal products for human and veterinary

medicinal products shall be paid as follows for each

manufacturing site:



1. The manufacture of medicinal products, with the exception

av 2 65 000 kr



2. Manufacturing of herbal remedies, some

topical medicines, traditional herbal

medicinal or homeopathic medicine 30 000 kr



section 8/entry into force: 01/01/2016

The fee for an application for authorisation of a professional production of medicinal products for human and veterinary use shall be paid as follows for each manufacturing site:



1. The manufacture of medicinal products, with the exception of 2 65 000 kr



2. Manufacturing of herbal remedies, some topical medicines, traditional herbal medicinal or homeopathic medicine 30 000 kr

Regulation (2015:465).



§ 9 the fee for the application for a permit for the establishment of

manufacture of medicines for a particular time

(extemporaneous drug preparations)



1. If the other condition for the production of

medicine is 26 000 SEK



2. If the other condition for the production of

drugs missing 58 500 kr



Authorisation of a clinical drug trial



section 10 of the fee for an application for authorisation to carry out a

clinical trials must be paid with 45 000 kr for

medicinal products for human use and for veterinary 22 500 SEK

medicines.



Chapter 3. Additional listing fees



/Rubriken expires U: 2016-01-01/

Sweden serves as the reference Member State in the

decentralised or mutual procedure



/Rubriken entry into force: 01/01/2016

Sweden serves as the reference Member State in a decentralised or mutual procedure



Authorisation of medicinal products for sale



1 §/expires U: 2016-01-01/

Fee for request to Sweden to work as

the reference Member State in a decentralised or

reciprocal procedure in connection with an application in a different

Member State concerning the authorisation of medicines for sale

shall be paid as follows:



1. medicinal products for Human use



(a)) a request where the product is accompanied by

full documentation 200 000 kr



b) abridged application 200 000 kr



c) request in which the medicinal product is a duplicate

both in Switzerland and in other Member States 30 000 kr



2. Medicinal products for veterinary use



(a)) a request where the product is accompanied by

full documentation 100 000 kr



b) abridged application 100 000 kr



c) request in which the medicinal product is a duplicate

both in Sweden and in another Member State, 15 000 kr



The fee for all routes of administration, strengths and

pharmaceutical form of the same drug name in the same request.



In addition to the fee under this section shall charge payable

According to Chapter 2. section 1 of this regulation.



1 section/entry into force: 01/01/2016

Fee for request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in a Member State concerning the authorisation of medicines for sale to be paid as follows:



1. medicinal products for Human use (a)) a request where the medicinal product supported by a full dossier 200 000 kr



b) abridged application 200 000 kr



c) request where the medicinal product constitutes a duplicate both in Sweden and in another Member country 30 000 kr



2. veterinary medicinal products (a)) a request where the medicinal product supported by a full dossier 100 000 kr



b) abridged application 100 000 kr



c) request where the medicinal product constitutes a duplicate both in Sweden and in another Member country 15 000 kr



The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug name in the same request.



In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 1 of this regulation. Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

Extension of an existing authorisation



/Rubriken entry into force: 01/01/2016

Extension of an existing authorisation



2 §/expires U: 2016-01-01/

For a request to Sweden to work as

the reference Member State in a decentralised or

reciprocal procedure in connection with an application in a different

Member State concerning the extension of an existing authorisation of

a medicinal product for human use is charge to 200 000 SEK.

a veterinary medicinal product is the fee to

100 000 € Fee applies to all forces and

pharmaceutical form of the same drug name submitted

for the assessment at the same time and for the same type

by amending the conditions for authorisation.



In addition to the fee under this section shall charge payable

According to Chapter 2. section 3 of this regulation.



2 section/entry into force: 01/01/2016

For a request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in a different Member country on the extension of an existing marketing authorisation of a medicinal product for human use is the fee to $200 For a veterinary medicinal product is the fee to $100 Fee covers all strengths and pharmaceutical form of the same drug names submitted for assessment at the same time and the same type of modification of the conditions for the approval.



In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 3 of this regulation. Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

Registration of herbal medicinal products and

extension of such registration



/Rubriken entry into force: 01/01/2016

Registration for the sale of traditional herbal medicinal products and extension of such registration



3 §/expires U: 2016-01-01/

Fee for a request to Sweden to work as

the reference Member State in a decentralised or

reciprocal procedure in connection with an application in a different

Member State shall be paid as follows:



1. Registration of a traditional

herbal medicine 100 000 kr



2. The extension of a registration of a

traditional herbal medicinal products 50 000 kr



In addition to the fee under this section shall charge payable

According to Chapter 2. 4 and 5 of this regulation.



3 section/entry into force: 01/01/2016

Fee for a request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in another Member State shall be paid as follows:



1. Registration of a traditional herbal medicinal product for 100 000 kr



2. The extension of a registration of a traditional herbal medicinal product for 50 000 kr



In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 4 and 5. Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

The registration of homeopathic medicinal products



/Rubriken entry into force: 01/01/2016

Registration for the sale of homeopathic medicine



4 §/expires U: 2016-01-01/

For a request to Sweden to work as

the reference Member State in a decentralised or

reciprocal procedure in connection with an application in a different

Member State on the registration of a homeopathic medicinal product

the fee amounts to 4,000. The same fee applies for

veterinary medicinal products. The charge relates to an individual

simple means, simple means in a dilution series or a

composite products with multiple ingredients.



In addition to the fee under this section shall charge payable

According to Chapter 2. paragraph 6 of this regulation.



4 section/entry into force: 01/01/2016

For a request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in a Member State for registration of sale of a homeopathic medicine is the fee to £ 400; the same fee applies for veterinary medicinal products. The charge relates to a single simple means, simple means in a dilution series or a composite medium with more ingredients.



In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 6. Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

Modification of an existing authorisation or of a

registration



/Rubriken entry into force: 01/01/2016

Modification of an existing authorisation or a registration for sale



Type II variation of an existing authorisation



§ 5/expires U: 2016-01-01/

For an application for a major variation of type II is

the fee for medicinal products for human and veterinary

medicines to the following amounts in the context of




(a)) the national procedure 10 000 kr



(b)) the reciprocal procedure in Sweden as

reference country 20 000 kr



c) the reciprocal procedure in Sweden as

Member State concerned, 6 000 kr



The fee for all routes of administration, strengths and

pharmaceutical form of the same drug name submitted

for the assessment at the same time.



§ 5/entry into force: 01/01/2016

For an application for a major variation of type II fee amounts for medicinal products for human use and veterinary medicinal products, the following amounts within the framework of a) the national procedure 10 000 kr



(b)) the reciprocal procedure with Sweden as the reference country 20 000 kr



c) the reciprocal procedure in Sweden which affected Member country 6 000 kr



The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. Regulation (2015:465).



Change of prescription status



6 §/expires U: 2016-01-01/

For a variation of the prescription status according to § 8 g

the medicines Act (1992:859) fee to 100 000

Ad For a veterinary medicinal product is the fee

to 50 000 kr. If the substance has already been the subject of

the same change and product characteristics and package leaflet in all

substantially equal amounts the fee in lieu of 10 000

SEK.



6 §/entry into force: 01/01/2016

For an application for an amended classification in Chapter 4. section 20 of the medicines Act (2015:315) fee to 100 000 SEK.

For a veterinary medicinal product, the fee amounts to € 50 000. If the substance has already been the subject of the same change and product characteristics and package leaflet are essentially equal amounts the charge instead of $1,000.

Regulation (2015:465).



/Rubriken expires U: 2016-01-01/

Type II variation of an existing registration of a

traditional herbal medicinal product or a homeopathic

medicines



/Rubriken entry into force: 01/01/2016

Type II variation of an existing registration for the sale of a traditional herbal medicinal product for human use or a homeopathic medicinal product



section 7/expires U: 2016-01-01/

For an application for a major variation of type II a

the registration fee amounts to the following amounts:



1. Traditional herbal medicinal product under



(a)) the national procedure 10 000 kr



(b)) the reciprocal procedure in Sweden as

Reference Member State 20 000 kr



c) the reciprocal procedure in Sweden as

Member State concerned, 6 000 kr



2. Homeopathic veterinary medicinal products (medicinal products for human use

and veterinary use) 2 000 SEK



To modify an existing registration of a traditional

herbal medicinal product relating to the fee all

routes of administration, pharmaceutical forms, strengths and with

the same drug names submitted for assessment in the same

point in time. For homeopathic medicines refer to the fee a

individual simple means, simple means in a dilution series or

a composite medium with more ingredients.



section 7/entry into force: 01/01/2016

For an application for a major variation of type II of a registration fee for the sale amounts for the following amounts:



1. Traditional herbal medicinal products within the framework of a) the national procedure 10 000 kr



(b)) the reciprocal procedure in Sweden as a reference Member State 20 000 kr



c) the reciprocal procedure in Sweden which affected Member country 6 000 kr



2. Homeopathic veterinary medicinal products (medicinal products for human and veterinary use) 2 000 SEK



To modify an existing registration of a traditional herbal medicinal product for human use refer to charge all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. For homeopathic medicines refer to charge a single simple means, simple means in a dilution series or a composite medium with more ingredients.

Regulation (2015:465).



Chapter 4. Annual fees



/Rubriken expires U: 2016-01-01/

Approved and registered medicines



/Rubriken entry into force: 01/01/2016

Approved and registered medicines for sale



1 §/expires U: 2016-01-01/

The annual fee shall be paid in the following amount:



1. medicinal products for Human use



a) medicinal products for human use, with the exception of the b-h 46 000 kr



b) additional strength and pharmaceutical form,

with the exception of the national license 22 500 SEK



c) duplicate 22 500 SEK



d) traditional herbal medicinal products,

natural remedies and certain topical medications 14 000 kr



e) radiopharmaceuticals and allergens 8 000 kr



f) dilution from the basic extract of allergen

(for each additional dilution) 250 kr



g) homeopathic medicines (for an individual

simple means, simple means in a dilution series

or a composite medium with several

constituents) 250 kr



h) parallel imported medicinal products (per

export country, shape, strength and

approval number) 6 000 kr



2. Medicinal products for veterinary use



a) veterinary medicinal products, with the

the exception of b-f 15 000 kr



b) additional strength and pharmaceutical form,

with the exception of the national licence 7 500 kr



c) duplicate 7 500 kr



d) natural remedies and certain topical medications 14 000 kr



e) homeopathic medicines (for an individual

simple means, simple means in a dilution series

or a composite medium with several

constituents) 250 kr



f) parallel imported medicinal products (per

export country, shape, strength and

approval number) 2 000 SEK



1 section/entry into force: 01/01/2016

The annual fee shall be paid in the following amount:



1. Medicinal products for human use (a)), with the exception of the b-h 46 000 kr



b) additional strength and pharmaceutical form, with the exception of the national license 22 500 SEK



c) duplicate 22 500 SEK



d) traditional herbal medicinal products, herbal remedies and certain topical medications 14 000 kr



e) radiopharmaceuticals and allergens 8 000 kr



f) dilution from the basic extract of allergen (for each additional dilution) 250 kr



g) homeopathic medicines (for a single simple means, simple means in a dilution series or a composite medium with more ingredients) 250 kr



h) parallel imported medicinal products (per country, shape, strength and approval number) 6 000 kr



2. veterinary medicinal products a) veterinary medicinal products, with the exception of (b) – (f) 15 000 kr



b) additional strength and pharmaceutical form, with the exception of the national licence 7 500 kr



c) duplicate 7 500 kr



d) natural remedies and certain topical medications 14 000 kr



e) homeopathic medicines (for a single simple means, simple means in a dilution series or a composite medium with more ingredients) 250 kr



f) parallel imported medicinal products (per country, shape, strength and approval number) 2 000 SEK

Regulation (2015:465).



Manufacturing



section 2 unless otherwise provided for in sections 3 to 5, is the annual fee for

the manufacture of medicinal products for human and veterinary

medicines to 46 000 kr. Fee relating to the manufacture of

a maximum of three pharmaceutical forms. For the production of

additional pharmaceutical forms, a fee of

14 000 SEK per year is paid. In the manufacture of sterile

medicine is also a surcharge of SEK 30 000 per year

paid.



For manufacturing that requires only limited

supervisory input is the annual fee to 14 000 SEK.



3 §/expires U: 2016-01-01/

For the manufacture of medicinal gases, traditional

herbal remedies, natural remedies, some topical

medicinal or homeopathic medicines is the annual fee

to 30 000 SEK for the manufacture of such drugs as

referred to in paragraph 2 (d), the medicines Act (1992:859)

the annual fee amounts to 30 000 SEK per manufacturing authorisations.



For manufacturing that requires only limited enforcement action

the annual fee amounts to 14 000 SEK.



The same fees as specified in the first and second paragraphs applies

for veterinary medicinal products. Regulation (2011:236).



3 section/entry into force: 01/01/2016

For the manufacture of medicinal gases, traditional herbal medicinal products, herbal remedies, some topical medications or homeopathic medicines is the annual fee to $30 000 for the manufacture of a medicinal product covered by a hospital except the annual fee amounts to 30 000 SEK per manufacturing authorisations.



For manufacturing that requires only limited enforcement effort is the annual fee to 14 000 SEK.



The same fees as specified in the first and second subparagraphs shall apply to veterinary medicinal products. Regulation (2015:465).



4 section for the manufacture of radiopharmaceuticals to hospitals or

medicines for dialysis treatment is the annual fee for

14 000 kr. The same fee applies for veterinary

medicines.



§ 5/expires U: 2016-01-01/

For the establishment for the manufacture of pharmaceutical products for a

particular time (extemporaneous drug preparations), the annual fee for

32 500 kr in cases where the other condition for manufacturing

missing. In the case of the other conditions for production are

the fee amounts to 13 000 kr.



§ 5/entry into force: 01/01/2016

For an annual fee to the extemporaneous drug preparations is 32 500 kr


in cases where the other condition of manufacture are missing. In the case of the other conditions for the manufacture, see fee amounts to 13 000 kr. Regulation (2015:465).



Chapter 5. Special charges



Scientific advice



section 1 the fee for the application for scientific advice is

to 45 000 kr.



Certificate



section 2 of the fee for the application for a certificate of authorization to manufacture

medicinal products and applications for the export of medicines

amounts to 950 kr.



paragraph 3 of the Fee for the issuance of the certificate of inspection of

production batch with respect to vaccines and blood products for

human use before release on the Swedish market in

cases where European certificate for batch release missing amounts

to $200.



Fee for the application for a certificate for the export of certain

batch of drug is 2 000 SEK.



Chapter 6. Payment of fees



Payment of the application fee, additional fee and

special fee



section 1 of the application fee, additional fee and special

fee must be paid by the applicant.



Payment of the annual fee



2 §/expires U: 2016-01-01/

The annual fee to be paid for:



1. the authorisation of medicinal products for sale: by

the holder of the authorisation as from the month following the

When the drug was approved for sale to the

year in which the marketing authorisation ceases to be valid,



2. registration of traditional herbal medicinal product:

the holder of the registration as of the month following the

the time the drug was registered until the year in which the

registration expires,



3. registration of homeopathic medicines: by the holder

of the registration from the year in which the product

registered until the year in which registration ceases

to apply,



4. manufacturing of pharmaceutical products: the holder of the

State as of the month following that in which

manufacturing authorization was announced until the year in which the

it expires.



Annual fee provided for in the first subparagraph 1 to 3 shall not be paid if

the medicine deregistered by 31 January.



2 section/entry into force: 01/01/2016

The annual fee to be paid for:



1. the authorisation of medicinal products for sale: by the mAh from the month following that in which the drug was approved for sale through the year in which the marketing authorisation ceases to be valid,



2. registration of traditional herbal medicinal products for sale: by the holder of the registration as of the month following that in which the product was registered for the year in which the registration expires;



3. registration of homeopathic medicinal products for sale: by the holder of the registration from the year in which the product was registered until the year in which the registration expires;



4. manufacturing of pharmaceutical products: by the permit holder as of the month following that during which the manufacturing authorization was given to the year in which the authorization expires.



Annual fee provided for in the first subparagraph 1 to 3 shall not be paid if the medicine deregistered by 31 January.

Regulation (2015:465).



paragraph 3 of the Fee payable to the Agency for

Special billing.



section 4 of the food and Drug Administration may, if there are special reasons, in

each case repay or reduce all

or part of a fee.



Chapter 7. Other provisions



Authorization



section 1 the Agency may notify the rules

necessary for enforcement of this regulation.



/Rubriken expires U: 2016-01-01/

Appeal



2 §/expire U:2016-01-01 by Regulation (2015:465)./

In 22 a of the Administrative Procedure Act (1986:223) is

provisions for an appeal to the public

Administrative Court.



Transitional provisions



2010:1167



1. This Regulation shall enter into force on January 1, 2011, when

Regulation (1993:595) on charges for the State

the control of medicines shall be repealed.



2. The repealed regulation continues to apply in respect of

fees relating to the period prior to the entry into force.